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Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02177786
Recruitment Status : Completed
First Posted : June 30, 2014
Results First Posted : June 11, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE June 26, 2014
First Posted Date  ICMJE June 30, 2014
Results First Submitted Date  ICMJE May 23, 2019
Results First Posted Date  ICMJE June 11, 2019
Last Update Posted Date November 5, 2019
Study Start Date  ICMJE June 2014
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
Change in eGFR From Baseline at Week 48 [ Time Frame: Baseline; Week 48 ]
The values of eGFR were calculated using the MDRD equation: eGFR = 175 x Serum Creatinine^-1.154 × age^-0.203 × 1.212 (if participant is black) × 0.742 (if female).
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2014)
Change in estimated glomerular filtration rate (eGFR) from baseline at Week 48 [ Time Frame: Up to 48 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
Percentage of Participants Achieving at Least a 30% Reduction From Baseline in Albuminuria (As Measured by Urine Albumin to Creatinine Ratio) at Week 48 [ Time Frame: Baseline; Week 48 ]
Baseline was the average of the last 2 values prior to randomization and the last value on or after the randomization date, but prior to or on the first dose date. Urine Albumin to Creatinine Ratio= urine albumin/urine creatinine.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2014)
Proportion of participants achieving at least a 30% reduction from baseline in proteinuria at Week 48 [ Time Frame: Up to 48 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease
Official Title  ICMJE A Phase 2, Double-Blind, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy, Safety, and Tolerability of GS-4997 in Subjects With Diabetic Kidney Disease
Brief Summary The primary objective of this study is to determine the effect of selonsertib (formerly GS-4997) on estimated glomerular filtration rate (eGFR) decline in participants with diabetic kidney disease (DKD). Participants will be randomized with a 1:1:1:1 allocation to receive 1 of 3 doses of selonsertib (2 mg, 6 mg, or 18 mg) or matching placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Kidney Disease
Intervention  ICMJE
  • Drug: Selonsertib
    Tablets administered orally once daily
    Other Name: GS-4997
  • Drug: Placebo to match selonsertib
    Tablets administered orally once daily
Study Arms  ICMJE
  • Experimental: Selonsertib 2 mg
    Participants will receive selonsertib 2 mg for 48 weeks.
    Intervention: Drug: Selonsertib
  • Experimental: Selonsertib 6 mg
    Participants will receive selonsertib 6 mg for 48 weeks.
    Intervention: Drug: Selonsertib
  • Experimental: Selonsertib 18 mg
    Participants will receive selonsertib 18 mg for 48 weeks.
    Intervention: Drug: Selonsertib
  • Placebo Comparator: Placebo to match selonsertib
    Participants will receive placebo to match selonsertib for 48 weeks.
    Intervention: Drug: Placebo to match selonsertib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2015)
334
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2014)
300
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Adult male or females with prior diagnosis of Diabetic Kidney Disease
  • Type 2 diabetes mellitus diagnosis for at least 6 months
  • eGFR (MDRD) at screening ≥ 15 mL/min/1.73m^2 to < 60 mL/min/1.73m^2
  • Urine albumin to creatinine ratio (UACR) as follows:

    • Stage/Stratum 3a: eGFR range 45 to < 60 mL/min; UACR ≥ 600 mg/g
    • Stage/Stratum 3b: eGFR range 30 to < 45 mL/min; UACR ≥ 300 mg/g
    • Stage/Stratum 4: eGFR range 15 to < 30 mL/min; UACR ≥ 150 mg/g
  • Receiving angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor blockers (ARB) at a minimum dose deemed appropriate for the individual by the investigator and be at a stable dose for the last three months

    • Individuals not on ACEi/ARB may be screened if there is documented intolerance to ACE inhibitor and/or ARB

Key Exclusion Criteria:

  • Type 1 diabetes mellitus
  • HbA1c > 9.5%
  • Non-diabetic kidney disease
  • UACR > 5000 mg/g on any measurement during screening
  • End stage renal disease (ESRD; receiving peritoneal dialysis, hemodialysis, or status post renal transplantation) or anticipated to occur within the treatment period
  • Unstable cardiovascular disease
  • Pregnant or lactating females

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02177786
Other Study ID Numbers  ICMJE GS-US-223-1015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP